Meningitis outbreak: More hearings in Congress today

Jul. 16, 2013

Marsha Blackburn / File

Written by

The Tennessean

A key committee of the U.S. House of Representatives will hold a hearing today on proposed regulations on compounding pharmacies to prevent another fungal meningitis outbreak.

The Senate has passed a bill to more clearly distinguish oversight, but a bill has yet to emerge from the House. The House Energy and Commerce Committee has eight witnesses scheduled to testify this afternoon, ranging from representatives for the compounding industry to a consumer safety advocate. U.S. Rep. Marsha Blackburn, R-Tenn., is vice chair of the committee.

The witnesses are Dr. James Woodstock, director of drug evaluation and research for the U.S. Food and Drug Administration; Jeffrey Francer, a lawyer for Pharmaceutical Research and Manufacturers of America; David Gaugh, vice president for regulatory affairs with the Generic Pharmaceutical Association; David G. Miller, president of the International Academy of Compounding Pharmacists; Carmen Calizone, executive director of National Association of Boards of Pharmacy; Kasey Thompson, vice president of American Society of Health-System Pharmacists; and Allen Coukell, senior director of drug and medical devices for The Pew Charitable Trusts.

The hearing is scheduled for 3 p.m. EST. The same committee also held a hearing in November.

Under the proposed Senate legislation, compounding manufacturers must register with the U.S. Food and Drug Administration and comply with good manufacturing processes. Traditional compounding pharmacies that mix smaller batches of drugs would remain under the purview of state regulators.

FDA Commissioner Margaret Hamburg testified in November that existing federal laws do not give her agency clear authority over compounding manufacturers.

“Unfortunately, we have an unclear, fragmented regulatory framework,” she said, adding that Congress needs to clarify her agency’s authority over large-scale, “nontraditional” compounders like NECC.

Although 1938 food and drug laws give the FDA authority over anything considered prescription medicine, the agency has traditionally left it to state agencies to oversee small-scale compounders such as neighborhood druggists.

But some members of Congress, including members of the House committee, criticized the agency for not exerting authority over New England Compounding Center, the company whose drugs have been directly linked to the outbreak, when it should have.

The ongoing fungal meningitis outbreak has sickened 749 people across the nation with illnesses ranging from injection site infections to fungal meningitis. Sixty-one people have died. Tennessee has been one of the hardest hit states, with 153 illnesses and 15 deaths.